BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING

    MDR report key: 5655823 · Received May 16, 2016

    Report

    Report Number
    0008010177-2016-00100
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    July 25, 2015
    Report Date
    May 2, 2016
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT THAT 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING WAS ALLEGED OF ISSUE S-11 (BREAKAGE DURING SURGERY) COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IT IS LIKELY THAT THE FAILURE WAS CAUSED BY TOO HIGH FORCES APPLIED DURING SCREW INSERTION/EXTRACTION OR TO INAPPROPRIATE MAINTENANCE OF THE DEVICE. THE INSTRUCTION FOR USE (90-01972 REV E 01-2014 ASNIS MICRO INSTRUMENTS IFU) WAS REVIEWED: "ONLY USE AN INSTRUMENT FOR ITS INTENDED PURPOSE. ALWAYS TREAT THE INSTRUMENT CAREFULLY TO AVOID SURFACE DAMAGE OR ALTERATIONS TO THE INSTRUMENT GEOMETRY. THE DESIGN OF THE INSTRUMENT MUST NOT BE MODIFIED IN ANY WAY. VISUALLY INSPECT CUTTING EDGES FOR SHARPNESS AND DAMAGE. BEFORE EVERY OPERATION, ENSURE THAT ALL DEVICES TO BE USED DURING THE OPERATION FUNCTION CORRECTLY WITH EACH OTHER. IN THE COURSE OF THE OPERATION, REPEATEDLY CHECK THAT THE CONNECTIONS REQUIRED FOR PRECISE POSITIONING BETWEEN THE IMPLANT AND INSTRUMENTS, OR BETWEEN THE INSTRUMENTS THEMSELVES, ARE SECURE. WARNINGS AND PRECAUTIONS ALL INSTRUMENTS AND IMPLANTS SHOULD BE VERIFIED FOR PROPER FUNCTION PRIOR TO EACH CLINICAL USE. THE USER MUST BE FAMILIAR WITH THE STATE OF- THE-ART AND THE INSTRUMENT AND IMPLANT FUNCTION PRIOR TO CLINICAL APPLICATION." [ORIGINAL STATEMENT(S)]. THE CLEANING AND STERILIZATION GUIDE (INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE L24002000) WAS REVIEWED: ''FUNCTIONAL CHECK FOR SCREWDRIVER BLADES DESCRIPTION AND FUNCTION: SCREWDRIVERS WITH DRIVE CONNECTIONS OF VARIOUS DESIGNS WITH OR WITHOUT SELF RETAINING FUNCTION. POTENTIAL FAILURE MODES: DEFORMATION OF THE BLADE (TWISTED). DEFORMATION OF THE BLADE (ROUNDED). CORRESPONDING DRIVE CONNECTION OF SCREW HEAD IS ROUNDED OR WORN. PREVENTIVE MAINTENANCE: REGULAR FUNCTIONAL CHECK AND VISUAL INSPECTION. REPLACE AND DO NOT USE IN CASE OF FAILURE. REGULAR FUNCTIONAL CHECK OF CORRESPONDING ITEMS (SCREWDRIVERS - SCREWS).'' [ORIGINAL STATEMENT(S)]. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NEVERTHELESS, A CAPA HAS BEEN OPENED AIMING TO REDUCE THE NUMBER OF COMPLAINTS RELATED TO THIS FAILURE. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA SUS VOLUNTARY EVENT REPORT # MW5057191. DURING PODIATRIC SURGERY, TWO SCREWDRIVERS BROKE: 1 SCREWDRIVER HAD A CRACKED TIP; 1 SCREWDRIVER BROKE INTO 3 SEVERAL PIECES. THE FRAGMENTS OF THE SECOND SCREWDRIVER WERE RECOVERED WITHOUT INJURY TO THE PTS. THE SURGICAL SITE WAS FRAGMENT FREE AS CONFIRMED BY C-ARM. AT THIS TIME, IT DOES NOT APPEAR THAT THIS WAS THE RESULT OF A USER ISSUE. THE PRODUCT WAS USED FOR ITS INTENDED PURPOSE FOR THE APPROPRIATE SIZE SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA SUS VOLUNTARY EVENT REPORT # MW5057191. DURING PODIATRIC SURGERY, TWO SCREWDRIVERS BROKE: 1 SCREWDRIVER HAD A CRACKED TIP; 1 SCREWDRIVER BROKE INTO 3 SEVERAL PIECES. THE FRAGMENTS OF THE SECOND SCREWDRIVER WERE RECOVERED WITHOUT INJURY TO THE PTS. THE SURGICAL SITE WAS FRAGMENT FREE AS CONFIRMED BY C-ARM. AT THIS TIME, IT DOES NOT APPEAR THAT THIS WAS THE RESULT OF A USER ISSUE. THE PRODUCT WAS USED FOR ITS INTENDED PURPOSE FOR THE APPROPRIATE SIZE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311199 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER LEIBINGER FREIBURG AE04

    Patients

    Seq Age Sex Outcome Treatment
    1 Other